The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.200discountsmokes.com, and determined that the cigarette products listed there are offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that several of your products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

Modified Risk Tobacco Product Violations

You describe products that you offer for sale on the website, http://www.200discountsmokes.comas being mild, light, or ultra light by referring to them as such in product labeling or advertising and adding the qualifiers “Lights,” “lighter,” “lightest,” “mild,” or “ultra light,”to the product names. Specifically, our review of the website revealed that you offer for sale products listed as: “Bond Lights (Special Selection)” and described on the website as “Bond Street Special Selection - A bit lighter”; Bond Street One cigarettes, described as “[t]his is a medium-light cigarette”; Camel Natural Flavor 4, 6, and 8 cigarettes, described as “[t]hree light varieties”; Davidoff Blue cigarettes, described as “…even lighter than the previous one”; Davidoff One cigarettes, described as “[t]he lightest version sold by Davidoff”; Dunhill Fine Cut White 100’s cigarettes, described as “the ultra light white”; Dunhill Infinite cigarettes, described as “…light, yet it has a very distinctive taste; it’s mild, yet it suggests so many different flavors”; Esse Special Gold 100’s cigarettes, described as “[t]he best portrayal of this cigarette would place it between lights and ultra lights cigarettes”; Esse Super Slims Field 100’s cigarettes, described as “[t]his variety is light and airy”; “Kent Lights Nr. 1 (Infina)”; “Kent Premium Lights Nr. 8 (Futura)”; “Kent Super Lights Nr. 4 (Neo)”; “L&M Lights (Blue)”; “L&M Super Lights (Silver Label)”; “Magna Blue (Lights)” cigarettes, described as having a “taste rather special in the context of light cigarettes”; “Marlboro Accent (Ultra Lights)”; “Marlboro Lights (Gold)”; “Pall Mall Blue (Lights)”; “Pall Mall Lights (Blue)”; “Pall Mall Ultra Lights (Amber)”; “Pall Mall Super Slims Blue (Lights) 100’s”; “Sobranie White Russian” cigarettes, described as “lighter”; “Sovereign Slim Ultra Lights 100’s”; Vogue Super Slims Bleue 100s cigarettes, described as “taste is smooth and mild”; “Winston Lights (Balanced Blue)”; and “Winston XS Blue NanoKings(mini) Cigarettes” and “Winston XS Silver NanoKings(mini) Cigarettes, described as “[a]n elegant line of light and ultra light cigarettes.”

In addition, your website promotes for sale the following tobacco products listed as:

Camel One cigarettes, described as “[t]he ultimate when it comes to low tar…” and as having an “extremely reduced quantity of tar and nicotine.”

Epique cigarettes, described as a “new slim line of cigarette [that] is great tasting yet provides less harmful chemicals than a full-flavor cigarette.”

“Esse Super Slims ONE 100’s” cigarettes, described as “[t]he ultimate when it comes to low tar and nicotine.”

Parliament brand cigarettes, with the description: “In time, you stop perceiving this, but with every new cigarette, you add to the quantity of nicotine and tar that enters your body. Parliament Cigarettes on the other hand, remove this effect, because their recessed filter doesn't allow you to touch the interior of the filter. It's simple, it's useful, and it has great consequences in the long run. Also, the recessed filters reduce the amount of additional substances generally associated to smoking because you don't inhale the smoke right near the filter. This is important if you take into account the innumerable possibly harmful substances you inhale during smoking.”

L&M Brand cigarettes, with the description, “[t]he tar is not particularly strong, which is beneficial for the smoker in the short and long run.”

A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because the website uses the descriptor “Lights,” “lighter,” “lightest,” “mild,” and “ultra light,” or similar descriptors or claims that the products or their smoke contain a reduced level of a substance or present a reduced exposure to a substance, or that the products are less harmful than other commercially marketed tobacco products, these products are modified risk tobacco products. Because these products are offered for sale to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

Flavored Cigarette Violations

Additionally,our review of the website, http://www.200discountsmokes.com, revealed that you offer for sale the following cigarettes: Aroma Rich Apple, Aroma Rich Rum Cherry, Kiss Super Slims Fresh Apple 100’s, Richmond Cherry, and Sobranie Slims Mints 100’s which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product(s). Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:

[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice…that is a characterizing flavor of the tobacco product or tobacco smoke.

As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.

If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) as their labeling or advertising is false or misleading because it makes the representation that the products contain, for example, apple, rum & cherry, cherry, or mint as a characterizing flavor of the tobacco products.

Conclusion and Requested Actions

The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.

It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, or any other websites or media in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.